(253 days)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Model 1: Natural Latex Powder Free Polymer Coated Examination Gloves, with Vanilla Scent
Model 2: Orange Latex Powder Free Polymer Coated Examination Gloves, with Citric Scent
Model 3: Pink Latex Powder Free Polymer Coated Examination Gloves
I am sorry, but the provided text is a 510(k) premarket notification for "ILLUSION Powder Free Latex Examination Gloves." This document does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI or medical imaging device. It is a regulatory approval document for disposable medical gloves.
Therefore, I cannot extract the specific details you requested regarding acceptance criteria and study information for an AI/imaging device from this text.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.